Study on Tocotrienol and Bevacizumab for Patients with Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a combination of treatments for metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study will explore the use of several medications, including tocotrienol, a derivative of vitamin D, and bevacizumab, a monoclonal antibody. Additionally, standard chemotherapy drugs such as capecitabine, fluorouracil, calcium folinate, and oxaliplatin will be used. A placebo will also be included in the study.

The purpose of the study is to compare the effects and side effects of the standard chemotherapy and bevacizumab treatment with the same regimen supplemented with tocotrienol. Participants will receive these treatments over a period of six months. The study aims to determine how well the cancer responds to these treatments and to monitor any side effects that may occur.

Throughout the study, participants will receive their treatments either orally or through intravenous infusion, depending on the specific medication. The study will track the progression of the cancer and assess the number of patients who remain free from disease progression after six months. This information will help researchers understand the potential benefits of adding tocotrienol to the existing treatment regimen for metastatic colorectal cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of metastatic colorectal cancer and ensuring the patient meets all inclusion criteria.

3 treatment plan

The treatment involves a combination of standard chemotherapy and bevacizumab, with or without tocotrienol. The specific regimen will be determined based on random assignment.

4 medication administration

The patient will receive capecitabine orally in capsule form. Fluorouracil, calcium folinate, bevacizumab, and oxaliplatin will be administered intravenously. A placebo may also be given orally as part of the study design.

5 treatment duration

The treatment will continue for a specified period, with regular monitoring to assess the patient’s response and any side effects. The primary goal is to evaluate the rate of progression-free patients at six months.

6 follow-up assessments

Regular follow-up assessments will be conducted to monitor the patient’s health status and the effectiveness of the treatment. Adjustments to the treatment plan may be made based on these assessments.

7 end of trial

The trial is expected to conclude by December 31, 2027. At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a type of cancer called adenocarcinoma of the colon or rectum, which has been confirmed by a medical test.
The cancer must have spread to other parts of the body, known as metastatic disease.
The patient should be planning to receive a specific treatment called FOLFOX or capecitabine, combined with a drug named bevacizumab.
The patient’s disease must be measurable according to a standard called RECIST 1.1, which is a way to assess how the cancer responds to treatment.
The patient should have a performance status between 0 and 2, which is a measure of their ability to perform daily activities.
The patient is expected to live for at least 3 more months.
The patient must agree to have blood samples taken for research purposes.
The patient must be 18 years of age or older.
Women who can have children and men with partners who can have children must use contraception during the study and for 6 months after the last dose. This includes methods like hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
The patient must have adequate bone marrow function, liver function, and kidney function, as shown by specific blood test results:

White blood cell count (WBC) of at least 3.0 x 10⁹/l or neutrophils (ANC) of at least 1.5 x 10⁹/l.
Platelet count of at least 100 x 10⁹/l.
Hemoglobin level of at least 6.0 mmol/l.
Serum bilirubin level no more than 2 times the upper limit of normal (ULN).
Serum transaminase level no more than 2.5 times the ULN.
Serum creatinine level no more than 1.5 times the ULN.

A urine test must show protein levels of 2+ or less. If the protein level is higher, a 24-hour urine test must show protein content of 1g or less.
The patient must provide written and verbal consent to participate in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.02.2020

Trial locations

Investigated drugs:

Bevacizumab is a medication used in this trial to treat metastatic colorectal cancer. It works by blocking a protein called VEGF, which helps tumors form new blood vessels. By inhibiting this process, bevacizumab can slow the growth of cancer by cutting off its blood supply.

Tocotrienol is being studied in this trial as a supplement to standard chemotherapy. Tocotrienols are a form of vitamin E that may have antioxidant properties. Researchers are investigating whether adding tocotrienol to the treatment regimen can enhance the effects of chemotherapy and bevacizumab in patients with metastatic colorectal cancer.

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It typically progresses by invading nearby tissues and organs, and can travel through the bloodstream or lymphatic system to distant sites. The disease often starts with the formation of polyps in the colon or rectum, which can become cancerous over time. As it advances, symptoms may include changes in bowel habits, abdominal pain, and weight loss. The spread of cancer cells to other organs, such as the liver or lungs, is a key characteristic of its metastatic nature. The progression can vary greatly among individuals, depending on various factors including the cancer’s genetic makeup and the patient’s overall health.

Trial ID:

2024-517075-21-00

Protocol code:

Toco-CoR

NCT ID:

NCT04245865

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Tocotrienol and Bevacizumab for Patients with Metastatic Colorectal Cancer

What is this study about?

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